Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
  • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
  • A61L29/12—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
  • A61L29/126—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
  • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
  • A61L27/40—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
  • A61L27/44—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix
  • A61L27/46—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix with phosphorus-containing inorganic fillers
• • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
  • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
  • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
  • Y10S623/00—Prosthesis, i.e. artificial body members, parts thereof, or aids and accessories therefor
  • Y10S623/92—Method or apparatus for preparing or treating prosthetic
  • Y10S623/923—Bone

Definitions

• the present invention relates to a bioimplant material and a method for producing the same.
• a contrast line using a contrast agent such as barium sulfate and oxidized stainless steel embedded in a catheter or the like may cause a tear or the like along the contrast line or the like, and is an anxious factor in strength.
• a material obtained by mixing a contrast agent into the material itself and having a contrast property may cause invasion of the living body due to the dissolution of the contrast agent.
• hydroxyapatite is known to have excellent affinity for living organisms, and has been clinically applied to artificial bones and the like. However, it is much harder than living tissue and lacks elasticity and flexibility, making it unsuitable for materials applied to soft tissues such as force catheters. Disclosure of the invention
• the present invention provides a function as a substitute for a long period of time without causing inflammation in a living body, has flexibility and elasticity, and has biocompatibility and contrast. High contrast and requires a contrast line It is an object of the present invention to provide an unnecessary bioimplant material.
• a bioimplant material comprising a mixture of a hydroxyapatite ultrafine powder having a particle size of 2 zm or less and a polymer or oligomer.
• a method for producing a bio-implantable material comprising drying or heating a wet-synthesized hydroxyapatite to form an ultrafine powder, and then mixing the resultant with a polymer or an oligomer.
• FIG. 1 and 2 are graphs showing the results of Example 1.
• FIG. 1 shows the changes in the tensile strength and tear strength of the silicone rubber depending on the amount of the hydroxyapatite (HA) added
• FIG. The figure shows the change in the thickness of the fibrous cap formed around the sample with the amount of droxapatite (HA) added.
• composition, shape or structure, mode of use, and the like of the bioimplant material of the present invention will be described in detail.
• the in "high Dorokishiapatai bets" in the present invention not only pure product whose chemical composition is represented by Ca 10 (P0 4) 6 ( OH) 2, 1 ⁇ 10% of Kabone bets instead of 0H ions ( C0 3) ions and fluorine, may contain such as chlorine ions. This also is the is to mainly sinterability.
• Hydroxyapatite having the above components has a CaZP molar ratio of 1.67, but is a calcium phosphate compound such as calcium-deficient apatite, tricalcium phosphate, tetracalcium phosphate, and octacalcium phosphate. Or a complex of two or more of them has almost the same function as hydroxyapatite.
• Hydroxyapatite fine powder is prepared by gradually lowering an aqueous solution of phosphoric acid to a 0.5M calcium hydroxide suspension and uniformly reacting with stirring, and filtering the amorphous hydroxypatite obtained at 60 ° C. After drying with C, it can be obtained using an ultra-fine pulverizer such as a jet mill. This is dried to eliminate foaming due to kneading with the polymer at 150 to 350 ° C and water evaporation during molding, and it is possible to produce a uniform composite material. At this point, the fine powder becomes a low crystalline hydroxyapatite and the primary particles are several hundred angstroms.
• Agglomerated secondary particles are about 2 microns, but are easily disintegrated and dispersed in a sufficient kneading process with the polymer using a kneader, emulsifier, or homogenizer. Particle dispersion of hundreds of angstroms not only has the effect of minimizing the strength loss of the composite, but can also be distributed between polymer chains, so that particles and matrix polymer can be distributed as in larger particles. There is no need to add a coupling material in consideration of the bonding strength and adhesive strength with the resin.
• the particle size is much smaller than the average cell size of about 1 micron, so the foreign particle reaction and cell phagocytic reaction caused by the particles are slight. . Furthermore, since the dissolution rate of hydroxyapatite is higher than that of highly crystalline ones, the effect of enhancing biocompatibility also appears earlier.
• the hydroxyapatite becomes highly crystalline and the particle surrounding soil starts to sinter, so that grain growth proceeds. Due to this, the above-mentioned problems are caused, and the strength of the composite material is only reduced. In addition, the tissue reaction is worse than the non-added one.
• hydroxyapatite has been known to grow from about 70 (TC or higher) . If the heat treatment temperature is 700 ° C or lower, foreign body giant cells may appear when implanted in a living body. However, the tissue reaction is poor, and it is considered to be most biocompatible when heated at 800 ° C to 900 ° C.However, we have conducted animal experiments and found that hydroxyapatite was heated at 800 ° C. It has been found that the silicone rubber composite material mixed with the above powder induces infiltration of inflammatory cells and worsens the tissue reaction as compared to the silicone rubber not mixed.
• Silicone-based oligomers have been used as tissue augmentation materials for cosmetic surgery, such as artificial breasts. However, they have a strong inflammatory tissue reaction and conversely cause the surrounding soft tissues to become extremely thick, causing problems such as dullness. O
• the hydroxyapatite used in the present invention is preferably in the form of ultra-fine particles. Even during production, since heating and growth at a high temperature cause grain growth accompanying crystallization, the hydroxyapatite should be dried at a temperature as low as possible and in a short time.
• An ideal composite material can be proposed that suppresses agglomeration by performing pulverization using an ultrafine pulverizer or the like, thereby suppressing the decrease in the strength of the base material and expressing the biocompatibility of hydroxyapatite. Also, by setting the temperature at such a low temperature, the cost of the manufacturing equipment can be kept low.
• the drying condition is to dry at 200 ° C or less in order to suppress grain growth and agglomeration of particles. However, freeze-drying, vacuum drying and the like are more effective.
• a heat treatment at about 400 ° C may be performed to promote the drying described above, but grain growth and agglomeration of the particles are inevitable.In this case, the particle size before heating is controlled to 5 zm or less. However, a somewhat good composite material can be obtained.
• the properties of the base material polymer or oligomer can be sufficiently improved. It was possible to significantly reduce biological reactions while maintaining the same.
• polymers examples include polyethylene, polypropylene, methyl methacrylate, polyurethane, polyester, acrylonitrile butadiene / styrene resin, polycarbonate, polysulfone, epoxy resin, silicone resin, and diacrylphthalate.
• Resin. Can be selected from furan resin. These resins are also S i C, contain S i 0 2, A 1 2 0 3, Zr0 2, Ti 0 2, W, Mo, stainless steel, the reinforcing material or other Huy La one made of titanium metal, etc. Is also good.
• a typical example of the oligomer is a silicone, but the oligomer described above may be another polymer material.
• the wet-synthesized ultra-fine hydroxyapatite powder with a particle size of 5 or less is dried at 400 ° C for 24 hours, then mixed with the addition-type silicone rubber compound at 5, 15, and 30% by weight, and thoroughly mixed. After that, it was formed into a 2 mm thick sheet. Thereafter, secondary vulcanization was performed.
• the tear strengths were 14, 24, 26, and 21 kgfZcm, respectively. It was confirmed that the tear strength was increased by the addition of hide mouth xiapatite, and that the added amount had a maximum value at around 15% by weight. ( Figure 1 )
• the fibrous cap formed around the composite material showed a tendency to be thinner when compared to the case of silicone alone and that the mixture containing hydroxyapatite was thinner and the tissue reaction was slight.
• the thickness of the coating around the composite material was about 365, 290, 25, and 150 m for hydroxyabutate at 0, 5, 15, and 30% by weight, respectively.
• the surrounding film was found to be the thinnest.
• the specific surface area contributing to a heat treatment at 60 ° C to about 95nf // g, 400 e C with those obtained by heat treatment of about 50 nF / g, 800 ° that is heat treated at C is about 15n g there were.
• the results show that drying at a lower temperature can increase the specific surface area, that is, the grain growth and agglomeration due to crystallization can be suppressed to a low level.
• the present invention functions as a substitute for a long period of time in vivo, prevents inflammation and the like, has flexibility and elasticity, and is excellent in biocompatibility and contrast properties. It has effects such as not requiring a component.

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• Health & Medical Sciences (AREA)
• Chemical & Material Sciences (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Composite Materials (AREA)
• Epidemiology (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• Engineering & Computer Science (AREA)
• Materials Engineering (AREA)
• Veterinary Medicine (AREA)
• Inorganic Chemistry (AREA)
• Dermatology (AREA)
• Medicinal Chemistry (AREA)
• Oral & Maxillofacial Surgery (AREA)
• Transplantation (AREA)
• Materials For Medical Uses (AREA)
• Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

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Publications (1)

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Citations (5)

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• 1993
  • 1993-12-10 JP JP34091493A patent/JP3472970B2/ja not_active Expired - Fee Related
• 1994
  • 1994-12-08 US US08/501,041 patent/US5766247A/en not_active Expired - Fee Related
  • 1994-12-08 CN CN94191562A patent/CN1119832A/zh active Pending
  • 1994-12-08 KR KR1019950703306A patent/KR960700676A/ko not_active Application Discontinuation
  • 1994-12-08 WO PCT/JP1994/002066 patent/WO1995015775A1/ja not_active Application Discontinuation
  • 1994-12-08 CA CA002156059A patent/CA2156059A1/en not_active Abandoned
  • 1994-12-08 EP EP95902928A patent/EP0684046A4/en not_active Withdrawn
  • 1994-12-09 TW TW083111494A patent/TW296345B/zh active

Patent Citations (5)

Non-Patent Citations (1)

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